U.S. patent number 10,750,949 [Application Number 16/128,957] was granted by the patent office on 2020-08-25 for guidewire with internal pressure sensor.
This patent grant is currently assigned to Opsens Inc.. The grantee listed for this patent is OPSENS INC.. Invention is credited to Claude Belleville.
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United States Patent |
10,750,949 |
Belleville |
August 25, 2020 |
Guidewire with internal pressure sensor
Abstract
The present document describes a pressure guidewire. It
comprises a shaft tube having a proximal section configured to
provide pushability to the pressure guidewire; a middle section
extending distally relative to the proximal section, the middle
section comprising a cut pattern configured to provide greater
flexibility in the middle section than the proximal section; and a
sensor housing section extending distally relative to the middle
section. The pressure guidewire further comprises an inner hypotube
comprising a proximal end portion and a distal end portion, the
inner hypotube positioned entirely radially inward of the shaft
tube and within at least the middle section, the proximal end
portion and the distal end portion of the inner hypotube being
joined to the shaft tube; and a tip pressure sensor positioned in
the sensor housing section.
Inventors: |
Belleville; Claude (Ville de
Quebec, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
OPSENS INC. |
Quebec |
N/A |
CA |
|
|
Assignee: |
Opsens Inc. (Quebec,
CA)
|
Family
ID: |
46050276 |
Appl.
No.: |
16/128,957 |
Filed: |
September 12, 2018 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190029523 A1 |
Jan 31, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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15918677 |
Mar 12, 2018 |
10154787 |
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14138392 |
May 15, 2018 |
9968260 |
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14030425 |
Sep 18, 2013 |
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13389319 |
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PCT/CA2011/001257 |
Nov 9, 2011 |
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61411722 |
Nov 9, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
5/02154 (20130101); A61B 5/6851 (20130101); A61M
25/09 (20130101); A61B 5/0084 (20130101); A61M
2205/3327 (20130101); A61M 2025/0002 (20130101); A61M
2025/09108 (20130101); A61M 2025/09183 (20130101); A61M
2025/09133 (20130101); A61M 2025/09083 (20130101); A61M
2025/09166 (20130101) |
Current International
Class: |
A61B
5/00 (20060101); A61B 5/0215 (20060101); A61M
25/09 (20060101); A61M 25/00 (20060101) |
References Cited
[Referenced By]
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Jan 2017 |
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WO |
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WO 2017/049392 |
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Mar 2017 |
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WO |
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Other References
Tohyama et al.. "A Fiber-Optic Silicon Pressure Sensor for
Ultra-Thin Catheters", The 8th International Conference on
Solid-State Sensors and Actuators, and Eurosensors IX, Stockholm,
Sweden, Jun. 25-29, 1995 (Jun. 25, 1995), p. 596, right col., line
1 to p. 598, left col., line 8, Fig. 3, 4. cited by applicant .
European Search Report issued in EP 11 83 9309, dated Mar. 20,
2014, in 1 page. cited by applicant .
International Search Report issued in PCT Application No.
PCT/CA2011/001257, dated Mar. 6, 2012, in 4 pages. cited by
applicant.
|
Primary Examiner: Messersmith; Eric J
Attorney, Agent or Firm: Benoit & Cote, Inc. Benoit; C.
Marc Caron; Charles-Andre
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is filed as a continuation application of U.S.
patent application Ser. No. 15/918,677, filed on Mar. 12, 2018,
which is a continuation application of U.S. patent application Ser.
No. 14/138,392 filed on Dec. 23, 2013, which is a continuation of
U.S. patent application Ser. No. 14/030,425 filed Sep. 18, 2013,
which is a continuation of U.S. patent application Ser. No.
13/389,319 filed Feb. 7, 2012, which is the US national phase
application of PCT/CA2011/001257, filed Nov. 9, 2011, and entitled
"GUIDEWIRE WITH INTERNAL PRESSURE SENSOR", which claims priority of
U.S. Provisional Application Ser. No. 61/411,722, filed on Nov. 9,
2010, the contents of which are hereby incorporated herein by
reference in their entirety.
Claims
The invention claimed is:
1. A pressure guidewire comprising: a shaft tube comprising: a
proximal section configured to provide pushability to the pressure
guidewire; a middle section extending distally relative to the
proximal section, the middle section comprising a cut pattern
configured to provide greater flexibility in the middle section
than the proximal section; and a sensor housing section extending
distally relative to the middle section; an inner hypotube
comprising a proximal end portion and a distal end portion, the
inner hypotube positioned entirely radially inward of the shaft
tube and within at least the middle section, the proximal end
portion and the distal end portion of the inner hypotube being
joined to the shaft tube; and a tip pressure sensor positioned in
the sensor housing section.
2. The pressure guidewire of claim 1, wherein the proximal and
distal end portions of the inner hypotube are sealed to the shaft
tube to prevent fluid from leaking through the cut pattern and into
the proximal section or sensor housing section of the shaft
tube.
3. The pressure guidewire of claim 1, wherein the proximal end
portion of the inner hypotube is joined to the shaft tube proximate
to and proximal of a proximal end of the cut pattern, and wherein
the distal end portion of the inner hypotube is joined to the shaft
tube proximate to and distal of a distal end of the cut
pattern.
4. The pressure guidewire of claim 1, wherein the proximal end
portion of the inner hypotube is joined to the shaft tube distal of
a proximal end of the shaft tube, and wherein the distal end
portion of the inner hypotube is joined to the shaft tube proximal
of the tip pressure sensor.
5. The pressure guidewire of claim 1, wherein a distal end of the
inner hypotube is positioned within the sensor housing section.
6. The pressure guidewire of claim 1, wherein the inner hypotube
comprises a tapered portion proximal to the distal end portion, the
tapered portion being tapered in a distal direction.
7. The pressure guidewire of claim 6, wherein the distal end
portion of the hypotube is enlarged relative to the tapered
portion.
8. The pressure guidewire of claim 1, wherein the cut pattern
comprises a spiral cut.
9. The pressure guidewire of claim 1, further comprising an optical
fiber extending through the shaft tube to the tip pressure
sensor.
10. The pressure guidewire of claim 1, wherein the sensor housing
section comprises an opening configured to let blood communicate
with tip pressure sensor.
11. A pressure guidewire comprising: a shaft tube having a length
and comprising: a proximal section configured to provide
pushability to the pressure guidewire; a middle section extending
distally relative to the proximal section, the middle section
comprising a cut pattern configured to provide greater flexibility
in the middle section than the proximal section; and a sensor
housing section extending distally relative to the middle section;
an inner hypotube having a length and comprising a proximal end
portion and a distal end portion, the inner hypotube positioned
entirely radially inward of the shaft tube and within at least the
middle section, the length of the inner hypotube being less than
the length of the shaft tube; a central lumen extending through the
pressure guidewire, the central lumen comprising a proximal portion
defined at least in part by the proximal section of the shaft tube,
the central lumen further comprising an intermediate portion
defined at least in part by the inner hypotube, and the central
lumen also comprising a distal portion defined at least in part by
the sensor housing section of the shaft tube; and a tip pressure
sensor positioned in the sensor housing section.
12. The pressure guidewire of claim 11, wherein the proximal and
distal end portions of the inner hypotube are sealed to the shaft
tube to prevent fluid from leaking through the cut pattern and into
the proximal section or sensor housing section of the shaft
tube.
13. The pressure guidewire of claim 11, wherein the proximal end
portion and the distal end portion of the inner hypotube are joined
to the middle section of the shaft tube.
14. The pressure guidewire of claim 11, wherein the proximal end
portion of the inner hypotube is joined to the shaft tube proximate
to and proximal of a proximal end of the cut pattern, and wherein
the distal end portion of the inner hypotube is joined to the shaft
tube proximate to and distal of a distal end of the cut
pattern.
15. The pressure guidewire of claim 11, wherein a distal end of the
inner hypotube is positioned within the sensor housing section.
16. The pressure guidewire of claim 11, wherein the inner hypotube
comprises a tapered portion proximal to the distal end portion, the
tapered portion being tapered in a distal direction.
17. The pressure guidewire of claim 16, wherein the distal end
portion of the hypotube is enlarged relative to the tapered
portion.
18. The pressure guidewire of claim 11, wherein the cut pattern
comprises a spiral cut.
19. The pressure guidewire of claim 11, further comprising an
optical fiber extending through the shaft tube to the tip pressure
sensor.
20. The pressure guidewire of claim 11, wherein the sensor housing
section comprises an opening configured to let blood communicate
with tip pressure sensor.
21. A pressure guidewire comprising: a shaft tube comprising: a
proximal section configured to provide pushability to the pressure
guidewire; a sensor housing section extending distally relative to
the proximal section; and a middle section disposed between the
proximal section and the sensor housing, the middle section being
discontinuous to provide more flexibility in the middle section
than the proximal section; an inner hypotube positioned entirely
radially inward of the shaft tube and within at least the middle
section; a tip pressure sensor positioned in the sensor housing
section; and wherein the inner hypotube seals off the shaft tube to
prevent leakage of fluid into the proximal section.
22. The pressure guidewire of claim 21, further comprising a sensor
lead wire or a communication means disposed proximally of the
sensor housing through the inner hypotube wherein the sealing of
the shaft tube by the inner hypotube prevents leakage of fluid onto
the sensor lead wire or the communication means.
Description
BACKGROUND
(A) Field
The subject matter disclosed generally relates to guidewires for
catheter use. More particularly, it relates to pressure guidewire
technology.
(b) Related Prior Art
Conventional Guidewires
Conventional guidewires are made using solid rods. They may be made
using a combination of different materials such as hard tempered
stainless steel and nitinol. Stainless steel provides good
pushability and torquability, and is relatively cheap, while the
nitinol provides good yield strength, i.e., does not permanently
deform. Nitinol is nickel/titanium alloy having superelastic
properties as known by those skilled in the art. One consideration
in designing guidewires is that welding nitinol to stainless steel
is extremely challenging.
Typical guidewires comprise three main parts as described
below.
The first part is the proximal section. For coronary use, the
proximal section, i.e., the length prior to the last 25 to 40 cm,
is made typically of 0.014'' outside diameter (OD) stainless steel.
Nitinol is not preferred in this section because it does not
provide a good pushability and torquability and it is fairly
expensive. This section always resides in the catheter guide, hence
not directly into the blood vessel. In use, a portion of this
section is outside the patient's body and is controlled by the
person using the guidewire. The typical length of the proximal
section is 140 cm or longer.
The second part is the middle section. The middle section is the
following 25 to 40 cm of flexible wire, before the tip portion,
i.e., the third portion extending further over another 3 to 4 cm.
The middle section is the section that navigates within the
coronary arteries. Guidewires may use a nitinol wire of about
0.0095'' OD over this section. In order to improve the navigability
within the vessel, i.e., having the ability to be threaded through
sharp corners within vessels, the distal 1 to 3 cm portion of the
middle section, may be slightly tapered, the outside diameter being
reduced roughly from 0.0095'' to 0.007''. This taper allows the
guidewire to bend with a circular shape, as opposed to a parabolic
shape in the case where the outside diameter is uniform. This
section can be bent quite seriously when navigating into the
vessels and hence, shape retaining is a desirable feature, although
not a necessary one.
The third part is the tip section. The tip is the last 3 to 4 cm of
the guidewire. It is made with a very thin tapered, or shaped
otherwise, spring tempered or hardened stainless steel core wire.
The core wire is surrounded by tungsten, platinum, palladium or
another wire winding providing smooth radiopaque tip. Tip section
can be pre-shaped prior to use by physician to ease the navigation
in any given circumstance.
Guidewire features are: Good trackability: Guidewire can be
threaded through tortuous vessels; Good pushability: Guidewire can
be pushed through tortuous vessels and through stenosis; Good
torque: Guidewire can be smoothly rotated to orient the tip within
the vessel; Soft tip: Guidewire is atraumatic for vessels; and Good
support: A balloon catheter can be slid over the guidewire without
the guidewire prolapsing or kinking.
Pressure Guidewire
A pressure guidewire is one that includes a tip pressure sensor.
Trade-offs are necessary to route the sensor lead wire(s) through
the guidewire, resulting in sub-optimal mechanical design. Existing
pressure guidewires typically comprises four main parts as
described below.
The first part is the proximal section. The proximal section is
made with a stainless steel hypotube (aka the proximal tube) having
typical OD of 0.014''. There are three sensor lead wires that are
routed through the proximal tube to connect to tip sensor.
The second part is the middle section. A solid core is welded to
the proximal section on one end, and to a sensor housing on the
other end. This solid rod is typically 27 cm long. The three wires
of typical piezo-resistive sensor run through the proximal tube and
on the wall of the core along the 27 cm. The three wires are
finally directed within the sensor housing (described below) to be
connected to the sensor.
The solid core and three wire assembly are protected either by
providing a polyimide tube covering the assembly, by providing a
spiral wound wire or other method for the assembly. The foregoing
covering method provides minimal mechanical benefit and therefore
they are used mostly as a protective sheath.
The third part of the pressure guidewire is the sensor housing. The
sensor housing is made with a hypotube with internal diameter (ID)
accommodating the tip sensor and an OD that is the continuity of
the proximal section OD. An opening is provided to the sensor
housing to let blood communicate with tip sensor.
The fourth part of the pressure guidewire is the tip section. The
tip section is provided at the end of the sensor housing. A
conventional tip section can be used as there is no wire to be
passed therethrough.
The critical part of above described pressure guidewires is the
middle section (second part above). Wall thickness of polyimide or
wire winding added to the size of the sensor lead wires that runs
along the solid core compromise the use of optimal solid core. More
specifically, the solid core is usually too thin for delivering
adequate pushability and torquability on one hand, and adequate
support for a balloon catheter on another hand.
SUMMARY
The device described herein optimizes the mechanical performance;
mode specifically it improves the pushability, torquability,
trackability and catheter support in the case of a pressure
guidewire.
As a first basic consideration, mechanical performance of prior
pressure guidewires can be improved if instead of routing the
sensor leads through a region toward the perimeter of the
guidewire, therefore relying on a thin solid core for the transfer
of torque, the sensor leads are routed through the center. It is
known that contribution to torque transfer from the central part of
a rod is lower than the contribution from the periphery of the same
and therefore, it is optimal sacrificing the central portion rather
than its periphery. This way, the torque per available surface area
is maximized.
The size of the distal portion of such a hypotube, the portion that
navigates within the coronaries, that delivers optimal flexibility
and torquability may however be susceptible to kinking, as it would
have to be a fairly thin hypotube if made of stainless steel. It is
then useful to provide a mechanism that protects this otherwise
vulnerable section against the risks of kinking. Protection against
kinking is very suitably provided by the continuity of a proximal
hypotube extending over, but being cut with a spiral or other
pattern.
The use of a nitinol tube, instead of stainless steel tube, within
the middle section of the guidewire would reduce the risk of
kinking. The joining of nitinol is however a challenging process
and there is a risk of leaving any of the guidewire distal parts
within the blood vessel. It is then also desirable to provide a
safety mechanism for retaining any of the distal parts of guidewire
in case the joining of nitinol was to fail.
The presence of a continuous shaft from the very proximal end of
the guidewire, up and after the sensor housing provides safety
features critical for medical devices.
Manufacturability is another consideration, where the guidewire
device needs to be produced in large quantity at the lowest
possible cost. Having a minimal amount of parts surely contributes
minimizing the manufacturing cost, as well as ease of assembly.
According to an embodiment, there is provided a pressure guidewire
comprising: a shaft tube comprising: a proximal section providing
pushability to the pressure guidewire; a middle section extending
further relative to the proximal section, the middle section being
cut according to a cut pattern thereby resulting in greater
flexibility in the middle section than in the proximal section; and
a sensor housing extending further relative to the middle section;
an inner hypotube installed substantially within the middle
section; a pressure sensor communication means routed to the sensor
housing through the proximal section and the middle section; and a
tip pressure sensor embedded within the sensor housing and
communicatively connected to the pressure sensor communication
means.
According to an aspect, the cut pattern comprises a spiral cut
pattern.
According to an aspect, the proximal section, the middle section
and the sensor housing are made from a unitary and continuous piece
of material.
According to an aspect, the unitary and continuous piece of
material comprises stainless steel.
According to an aspect, the pressure guidewire further comprises a
window through the shaft tube giving access to the inner hypotube
for welding, soldering or bonding the inner hypotube within the
middle section of the shaft tube.
According to an aspect, the pressure guidewire further comprises a
small piece of material in contact with a wall of the inner
hypotube and protruding within the window through the shaft tube,
the small piece of material being welded to inner hypotube.
According to an aspect, the inner hypotube comprises nitinol and
the shaft tube comprises stainless steel.
According to an aspect, the middle section has two ends and
comprises two windows, each one of the two windows located at a
respective one of the two ends of the middle section and thereby
providing two areas for welding, soldering or bonding the inner
hypotube within the middle section of the shaft tube.
According to an aspect, the pressure guidewire further comprises an
adhesive or solder for joining the inner hypotube and the shaft
tube.
According to an aspect, the inner hypotube and the shaft tube are
made of stainless steel.
According to an aspect, the inner hypotube comprises a distal
portion having a diameter which is profiled, thereby constituting a
profiled portion.
According to an aspect, the tip pressure sensor comprises an
optical pressure sensor for measuring a pressure of a fluid in a
blood vessel in which the pressure guidewire is inserted.
According to an aspect, the pressure guidewire further comprises a
band to which is fixed the pressure sensor communication means.
According to an aspect, the sensor housing comprises a window for
welding or bonding the band to the shaft tube.
According to an aspect, the inner hypotube comprises a nitinol
hypotube.
According to an aspect, the distal portion of the profile portion
of the inner hypotube is enlarged.
According to an aspect, both ends of the inner hypotube are bonded
to the shaft tube with an adhesive.
According to an aspect, the pressure sensor communication means
comprises an optical fiber.
According to an aspect, the pressure sensor communication means is
also routed within the inner hypotube.
According to an aspect, the pressure sensor communication means has
an end providing a connection to the tip pressure sensor.
According to an aspect, the pressure guidewire further comprises a
soft atraumatic tip extending further relative to the sensor
housing.
According to an embodiment, there is provided a pressure guidewire
comprising: a proximal section of shaft tube providing pushability
to the pressure guidewire; a middle section of shaft tube being the
extension of proximal section, the middle section having greater
flexibility than the proximal section; an inner hypotube installed
substantially within the middle section and providing middle
section with desired mechanical characteristics; a sensor housing
extending further relative to middle section; a pressure sensor
communication means routed through portion of the sensor housing
and through the proximal and middle sections of shaft tube, the
pressure sensor communication means having an end; and a tip
pressure sensor embedded within sensor housing.
According to an embodiment, there is provided a pressure guidewire
comprising: a shaft tube with a proximal section delivering good
pushability; the same shaft tube comprising a middle section having
a flexibility, the flexibility of the flexible middle section being
provided by way of cutting the hypotube over the middle section; an
inner hypotube installed substantially within the middle section
for providing desired mechanical characteristics to the middle
section; the same shaft tube with the distal section cut with a
different pattern for offering same rigidity as proximal section
for receiving and protecting a tip pressure sensor, and providing
an opening for blood pressure to communicate with pressure sensor;
a tip section connected and extending further to the sensor
housing; and a tip pressure sensor located within the sensor
housing, with a communication means routed through portion of
sensor housing, and inner hypotube and shaft tube.
According to another embodiment, there is provided a pressure
guidewire comprising: a shaft tube with a proximal section
delivering good pushability; the same shaft tube comprising a
flexible middle section having a flexibility, the flexibility of
the middle section being provided by way of laser cutting the
hypotube over the middle section; a nitinol inner hypotube
installed substantially within the middle section for providing
desired mechanical characteristics to the middle section; a nitinol
inner hypotube being joined at both ends to corresponding
overlapped sections with proximal shaft tube and sensor housing;
the same shaft tube with the distal section cut with a different
pattern for offering same rigidity as proximal section for
receiving and protecting a tip pressure sensor, and providing an
opening for blood pressure to communicate with pressure sensor; a
tip section connected and extending further to the sensor housing;
and a tip pressure sensor located within the sensor housing, with a
communication mean routed through portion of sensor housing, and
inner hypotube and shaft tube.
According to an embodiment, there is provided a pressure guidewire
comprising: a shaft tube comprising: a proximal section configured
to provide pushability to the pressure guidewire; a middle section
extending distally relative to the proximal section, the middle
section comprising a cut pattern configured to provide greater
flexibility in the middle section than the proximal section; and a
sensor housing section extending distally relative to the middle
section; an inner hypotube comprising a proximal end portion and a
distal end portion, the inner hypotube positioned entirely radially
inward of the shaft tube and within at least the middle section,
the proximal end portion and the distal end portion of the inner
hypotube being joined to the shaft tube; and a tip pressure sensor
positioned in the sensor housing section.
According to an aspect, the proximal and distal end portions of the
inner hypotube are sealed to the shaft tube to prevent fluid from
leaking through the cut pattern and into the proximal section or
sensor housing section of the shaft tube.
According to an aspect, the proximal end portion of the inner
hypotube is joined to the shaft tube proximate to and proximal of a
proximal end of the cut pattern, and wherein the distal end portion
of the inner hypotube is joined to the shaft tube proximate to and
distal of a distal end of the cut pattern.
According to an aspect, the proximal end portion of the inner
hypotube is joined to the shaft tube distal of a proximal end of
the shaft tube, and wherein the distal end portion of the inner
hypotube is joined to the shaft tube proximal of the tip pressure
sensor.
According to an aspect, a distal end of the inner hypotube is
positioned within the sensor housing section.
According to an aspect, the inner hypotube comprises a tapered
portion proximal to the distal end portion, the tapered portion
being tapered in a distal direction.
According to an aspect, the distal end portion of the hypotube is
enlarged relative to the tapered portion.
According to an aspect, the cut pattern comprises a spiral cut.
According to an aspect, the pressure guidewire further comprises an
optical fiber extending through the shaft tube to the tip pressure
sensor.
According to an aspect, the sensor housing section comprises an
opening configured to let blood communicate with tip pressure
sensor.
According to an embodiment, there is provided a pressure guidewire
comprising: a shaft tube having a length and comprising: a proximal
section configured to provide pushability to the pressure
guidewire; a middle section extending distally relative to the
proximal section, the middle section comprising a cut pattern
configured to provide greater flexibility in the middle section
than the proximal section; and a sensor housing section extending
distally relative to the middle section; an inner hypotube having a
length and comprising a proximal end portion and a distal end
portion, the inner hypotube positioned entirely radially inward of
the shaft tube and within at least the middle section, the length
of the inner hypotube being less than the length of the shaft tube;
a central lumen extending through the pressure guidewire, the
central lumen comprising a proximal portion defined at least in
part by the proximal section of the shaft tube, the central lumen
further comprising an intermediate portion defined at least in part
by the inner hypotube, and the central lumen also comprising a
distal portion defined at least in part by the sensor housing
section of the shaft tube; and a tip pressure sensor positioned in
the sensor housing section.
According to an aspect, the proximal and distal end portions of the
inner hypotube are sealed to the shaft tube to prevent fluid from
leaking through the cut pattern and into the proximal section or
sensor housing section of the shaft tube.
According to an aspect, the proximal end portion and the distal end
portion of the inner hypotube are joined to the middle section of
the shaft tube.
According to an aspect, the proximal end portion of the inner
hypotube is joined to the shaft tube proximate to and proximal of a
proximal end of the cut pattern, and wherein the distal end portion
of the inner hypotube is joined to the shaft tube proximate to and
distal of a distal end of the cut pattern.
According to an aspect, a distal end of the inner hypotube is
positioned within the sensor housing section.
According to an aspect, the inner hypotube comprises a tapered
portion proximal to the distal end portion, the tapered portion
being tapered in a distal direction.
According to an aspect, the distal end portion of the hypotube is
enlarged relative to the tapered portion.
According to an aspect, the cut pattern comprises a spiral cut.
According to an aspect, the pressure guidewire further comprises an
optical fiber extending through the shaft tube to the tip pressure
sensor.
According to an aspect, the sensor housing section comprises an
opening configured to let blood communicate with tip pressure
sensor.
According to an embodiment, there is provided a pressure guidewire
comprising: a shaft tube comprising: a proximal section configured
to provide pushability to the pressure guidewire; a sensor housing
section extending distally relative to the proximal section; and
middle section disposed between the proximal section and the sensor
housing, the middle section being discontinuous to provide more
flexibility in the middle section than the proximal section; an
inner hypotube positioned entirely radially inward of the shaft
tube and within at least the middle section; a tip pressure sensor
positioned in the sensor housing section and having a sensor lead
wire or a sensor communication means disposed proximally of the
sensor housing through the inner hypotube; and wherein the inner
hypotube seals off the shaft tube to prevent leakage of fluid into
the proximal section.
According to an aspect, the pressure guidewire further comprises a
sensor lead wire or a communication means disposed proximally of
the sensor housing through the inner hypotube wherein the sealing
of the shaft tube by the inner hypotube prevents leakage of fluid
onto the sensor lead wire or the communication means.
As will be realized, the subject matter disclosed and claimed is
capable of modifications in various respects, all without departing
from the scope of the claims. Accordingly, the drawings and the
description are to be regarded as illustrative in nature, and not
as restrictive and the full scope of the subject matter is set
forth in the claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Further features and advantages of the present disclosure will
become apparent from the following detailed description, taken in
combination with the appended drawings, in which:
FIG. 1 is a schematic diagram which illustrates partial side view
of an embodiment of the pressure guidewire;
FIG. 2 is a partial perspective view showing the interfacing
portion between the proximal and middle sections of pressure
guidewire of FIG. 1;
FIG. 3 is a partial perspective view showing the interfacing
portion between the middle and sensor housing sections of the
pressure guidewire of FIG. 1;
FIG. 4 is a schematic showing the profiling, in part, of the distal
end of inner tube of the pressure guidewire of FIG. 1;
FIG. 5. is a perspective view showing the tip section of pressure
guidewire of FIG. 1;
FIGS. 6A and 6B are perspective views showing the small piece
fitted to join or interlock nitinol inner tube to shaft tube;
and
FIG. 7 is a schematic diagram showing blood vessels with a cut-out
portion in which a pressure guidewire is inserted.
It will be noted that throughout the appended drawings, like
features are identified by like reference numerals.
DETAILED DESCRIPTION
Referring now to the drawings, and more particularly to FIGS. 1 to
6, there is shown an embodiment of a pressure guidewire 10.
The general design for the pressure guidewire shown in FIG. 1
herein, although it is made of fewer parts than prior art pressure
guidewires, it is also made of same four sections, namely, the
proximal section 12, the middle section 14, the sensor housing
section 15 and the tip section 16. Although, as it will become
clear hereinafter, the first three sections 12, 14 and 15 are to
some extent made of the continuity of the same shaft tube 18, the
above sections of shaft tube 18 may also be called herein after as
proximal section 12, middle section 14 and sensor housing section
15.
According to an embodiment, the proximal section 12 is made of a
stainless steel hypotube, with an OD of about 0.014'' and by way of
non limiting example with an ID of about 0.009''. The proximal
section is used to push other more distal sections of the pressure
guidewire within the vasculature. The proximal section resides
within the guiding catheter at one end, with the other end exiting
the patient through the introducer (not shown), therefore allowing
the physician to remotely control the pressure guidewire within the
blood vessel, such as pushing and torquing the wire. According to
an embodiment, the length of the sensor housing 15 is in a range
between 1 mm to 3.5 mm. According to an embodiment, the length of
the sensor housing 15 is 2.5 mm.
The middle section is the one that faces the most challenging
trade-offs. The middle section 14 must not damage the vessel and
hence it must be fairly flexible. It must however transmit the
torque for better navigability, be stiff enough to deliver a good
pushability and provide a good support for an angioplasty balloon.
The middle section can be made by extending the proximal section 12
further, but it would be too stiff to navigate within the vessels.
On the other hand, the middle section 14 can be softened by cutting
the tube as a spiral or other cutting patterns as known by those
skilled in the art. Those skilled in the art also know that such
cut patterns are achieved using laser, etching and other processes.
Spiral cutting the tube would result in a very soft section whether
the pitch is high or low, and would not deliver any of the required
tensile force and torque response. Other non continuous cut
patterns can provide adequate tensile force, but the stiffness is
controlled by adjusting the pitch and cut pattern. It is however
difficult to provide a smooth and continuous variation of
stiffness. There is also a critical safety challenges when torquing
such a cut patterned guidewire as the torque induced stresses are
concentrated in narrow cut regions of the guidewire, hence
potentially provoking guidewire failure.
Using the device described hereinafter it is possible to control
safely the mechanical performance of the middle section 14 by way
of a) extending the proximal section 12 further; b) cut this
extended section to soften it; and c) combining this cut section
with an additional inner hypotube 20 overlapping the whole cut
region of middle section 14, the inner hypotube geometry being
chosen such that the desired mechanical characteristics are
achieved. The middle section 14 is the continuity of the proximal
section 12, where the portion corresponding to the 27 cm middle
section 14 of the shaft tube 18 is cut, such as a spiral cut shaft
tubing 22 according to one embodiment. The spiral cut section of
the shaft tubing 22 does not provide any significant tensile
strength nor does it provide significant bending or torque
strength.
The inner hypotube 20 is inserted within the shaft tube 18 such
that it overlaps the middle section 14, where the tubing is cut.
The outside diameter (OD) of the inner hypotube 20 fits the inside
diameter (ID) of shaft tube 18 and can be of 0.009'' in an
embodiment. The ID of the inner hypotube 20 must accommodates the
sensor lead wire, or communication means (not shown in FIG. 1), as
is the case of the ID of the shaft tube 18. Sensor communication
means can be made fairly small, especially if optical fiber is
used, so the inner hypotube 20 can provide the desired mechanical
properties. By way of another non-limiting example, inner hypotube
ID can be of 0.005''.
One problem if such an inner hypotube 20 was used alone is that it
may not provide adequate resistance against kinking. In the absence
of the spiral cut shaft tubing overlay, or other cut pattern, a
more conventional design would involve the addition of an elastomer
coating to bring the outer diameter of the inner tube to a similar
diameter as that of the shaft tube 18 (i.e., the stainless steel
hypotube). However, this would not improve the resistance against
kinking, which is a safety consideration.
Another safety issue is the risk of leaving parts inside the
patient as a result of joint failure between inner tube and
proximal tube or sensor housing. In case of a joint failure in more
conventional designs, such as the one proposed in U.S. Pat. No.
5,085,223 and Patent appl. No. US2010/0318000, the risk of leaving
the distal parts of the guidewire within the blood vessel in case
of joint failure is quite important. The proposed design mitigates
this risk by providing a spiral cut pattern external tube that
covers an inner hypotube, the inner tube providing most of the
mechanical characteristics of the middle section. In case of joint
failure resulting from applying a pulling force too strongly, the
spiral cut tube will collapse over and grip the inner hypotube 20,
thereby bringing along the distal portion of the guidewire.
The spiral cut shaft tubing 22, when provided with an inner
hypotube 20, delivers the desired mechanical characteristics.
Stiffness (flexibility), torque transfer, pushability and support
are provided by the inner hypotube 20. Inner hypotube 20 dimensions
are easily adapted to provide optimal mechanical performance. On
the other hand, kink resistance, distal parts safety retainer, and
guidewire outside diameter continuity are provided by the spiral
cut shaft tubing 22. It is worth mentioning that kink resistance
provided by the spiral cut section is useful mostly in cases where
the inner hypotube is not nitinol, e.g., it is useful when inner
hypotube is stainless steel.
As shown by FIG. 4, it is also desirable to shape the outside
diameter of the inner tube, especially over the last 1 to 3 cm, in
order to further improve trackability. In this case, the external
diameter of the distal portion of the inner hypotube 20 can be
slightly grinded to taper its outer diameter 40 and hence,
optimizing mechanical response.
The very end 41 of the inner hypotube 20, the portion that fits
within the sensor housing section, should be enlarged, e.g., to the
same diameter as its proximal section, so as to assure a good joint
with the internal wall of the sensor housing section 15 (see FIGS.
1, 5 and 6). The very end 41 of the inner hypotube being enlarged
assures a better joint for at least two reasons. One is that the
gap between the inner hypotube and the internal surface of the
sensor housing is minimized, which in turns optimizes the shear
strength of the adhesive or soldering in between the sensor housing
internal diameter and outside diameter of the very end 41 of inner
hypotube. Another important reason is that an enlarged portion will
have a much lower internal stress. When using nitinol, the risk of
reaching a stress level corresponding to the first plateau of
nitinol stress to strain curve as known by those skilled in the
art, is much lower. When such first plateau is reached, the strain
induced within a nitinol tubing is increasing dramatically, which
may provoke a delamination of the adhesive or soldering, which in
turn may cause the failure of the joint.
One method of joining the inner hypotube 20 to the ends of middle
section 14 of shaft tube 18 is shown in FIG. 2. A window 32 is
provided through the wall of the shaft tube 18, where the inner
hypotube 20 is to be welded. The inner hypotube 20 is slid past the
window and welded to the middle section 14 using a laser beam or
other suitable welding or joining means. The laser beam melts and
joins together the edges of the window 32 to the inner hypotube 20
and therefore, secures the two parts together. It is also possible
to use the same window 32 to apply adhesive at the joint between
the inner and outer tubes. It is also possible to weld the tubes
together without such window by heating the outer surface of the
outer tube such that it welds to inner tube. Such heat can be
generated using a laser, an electron beam or another heat
source.
Similar methods apply for joining the inner hypotube 20 to the
other end of middle section 14, where another window 26 (FIG. 3) is
provided at the distal end of middle section 14 of shaft tube 18.
According to an embodiment, the length of windows 32 and 26 is in a
range between 0.2 mm to 0.5 mm. According to an embodiment, the
length of windows 32 and 26 is 0.3 mm. Both ends of inner hypotube
20 extend a little further past the position of windows 26 and
32.
Without the presence of an inner hypotube 20 within the cut middle
section 14, blood may leak inside the shaft tube 18, which
constitutes a fairly large volume, which in turn may cause
biocompatibility issues. The presence of the inner hypotube 20
seals off the inside of the shaft tube 18 where it is cut.
The sensor housing section 15 is made of the very last 2 to 3 mm of
the shaft tube 18. The spiral cut, or other cut patterns, stops
some 2 to 3 mm before the end of the shaft tube 18, where the
sensor 34 (see FIG. 3) is to be fitted. A sensor joining window 28
is provided to bond or to fix the sensor 34 within the sensor
housing section 15. Blood pressure is applied to sensor 34 via
opening 30. In the present description, sensor 34 comprises a
pressure sensor. According to an embodiment, the length of the
opening 30 is in a range between 0.2 mm to 0.5 mm. According to an
embodiment, the length of the opening 30 is 0.3 mm. According to an
embodiment, the diameter of the sensor joining window 28 is in a
range between 0.1 mm to 0.3 mm. According to an embodiment, the
diameter of the sensor joining window 28 is 0.2 mm. According to an
embodiment, the pressure sensor comprises an optical pressure
sensor.
A radiopaque marker band 36 may be located in the sensor housing
section 15 to help in localizing the pressure guidewire in the
vessels. The marker band, or otherwise similar non radiopaque band,
main purpose is however to allow easy assembly of the sensor within
the sensor housing. It is indeed preferable to avoid the
application of hard adhesive directly on sensor head. The marker
band 36 can be bonded to the pressure sensor communication means
(e.g., optical fiber) as a pre-assembly in an environment allowing
the control of adhesive flow. The sensor 34 is secured within
pressure guidewire by bonding the marker band 36, or other non
radiopaque band, to the sensor housing section 15 using sensor
joining window 28.
A tip section 16 (FIG. 5) is provided at the end of the sensor
housing section 15. A conventional atraumatic tip section 16 shown
in FIG. 3 can be used as there is no sensor lead wire to be passed
therethrough.
Having similar materials for shaft tube 18 and inner hypotube 20,
such as stainless steel, makes the above welding process fairly
simple and reliable. It may however be desirable to use dissimilar
materials that cannot easily be welded together. For example, it is
desirable to use shaft tube 18 made of stainless steel for
providing a good pushability, while it is also desirable to use
nitinol for the inner hypotube 20 for its superior yield strength
and lower elastic modulus. It is well known by those skilled in the
art that those two materials are not easily welded together, at
least not without an intermediate material.
The present description also discloses a method for joining
together those dissimilar materials. FIG. 6 shows one method of
joining an inner hypotube made of nitinol to a stainless steel
middle section 14 hypotube. The inner hypotube 52 is slid within
the shaft tube 18 to overlap the cut section, and fed through past
the windows 26 and 32 (only window 26 shown in FIGS. 6A and 6B). A
small piece 50 of nitinol that fits in the windows is machined,
inserted into the window 32 to get in contact with the inner
hypotube 52 once in place, and laser welded to the inner hypotube
52, interlocking the two parts together. The small piece 50 then
prevents the inner hypotube 52 from sliding within shaft tube 18. A
small amount of adhesive can also be added to eliminate any
movement of the small piece 50 relative to shaft tube windows 28
and 32.
Another method of joining the above inner hypotube 52 to stainless
steel shaft tube 18 is to use an intermediate material, for example
nickel, that can be welded to both nitinol and stainless steel. A
small piece 50 made of nickel can be laser welded to inner hypotube
52 first. A small hole in the center 51 can be provided to promote
heat transfer to inner hypotube 52. The inner hypotube 52 is then
interlocked to proximal section 12 as described above. The edges of
the small piece 50 of nickel can then be laser welded to shaft tube
18. In this case, no direct welding of nitinol to stainless steel
occurs and therefore, no brittle interface is created.
Another method involves the use of adhesive to bond the nitinol
inner hypotube 20 to the stainless steel shaft tube 18. The same
parts can also be soldered together and by any other methods known
by those skilled in the art.
It can be appreciated that the design is made with one single
uniform part, from proximal section 12 to the sensor housing
section 15, and therefore the guidewire 10 is very smooth with
minimum mechanical steps.
The manufacturability of this design is quite easy and very
efficient as the number of parts is minimized.
The mechanical properties can be optimized by varying the
respective wall thicknesses of inner hypotube 20 and shaft tube
18.
The pitch of the spiral cut or other laser cut pattern can be
varied ideally from a larger pitch to a shorter one when
approaching the sensor housing section 15. Sharp turns are expected
to arise in the region of the sensor housing section 15, near the
tip of the guidewire 10 and therefore, it would be best if the
pitch of the laser cut pattern was reduced near the sensor housing
section 15 to allow a smoother bending of the cut shaft tubing
22.
For improved safety, the spiral cut pattern provides a retainer for
distal portions of guidewire. Risks of leaving parts inside patient
body are therefore minimized.
There will be an optical connector (not shown) at the very proximal
end of the guidewire 10.
As known by those skilled in the art, above described pressure
guidewire can be coated with different material such as Teflon or
hydrophilic coating so as to reduce friction against wall of
vessels and/or guiding catheter.
Now referring to FIG. 7, there is shown blood vessels with a
cut-out portion in which a pressure guidewire 10 is inserted.
While preferred embodiments have been described above and
illustrated in the accompanying drawings, it will be evident to
those skilled in the art that modifications may be made without
departing from this disclosure. Such modifications are considered
as possible variants comprised in the scope of the disclosure.
* * * * *